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FDA 510(k)

G7 ACETABULAR SYSTEM

K-Number: K121874 · 2012-11-23

ApplicantBiomet Manufacturing Corp
Decision Date2012-11-23
Product CodePBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

G7 ACETABULAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2012-11-23 under 510(k) number K121874. The device is classified under product code PBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G7 ACETABULAR SYSTEM?

G7 ACETABULAR SYSTEM is a medical device that received FDA 510(k) clearance on 2012-11-23. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K121874.

When did G7 ACETABULAR SYSTEM receive FDA 510(k) clearance?

G7 ACETABULAR SYSTEM received FDA 510(k) clearance on 2012-11-23, under 510(k) number K121874.

Who is the listed applicant for G7 ACETABULAR SYSTEM?

The FDA 510(k) record lists Biomet Manufacturing Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G7 ACETABULAR SYSTEM?

The FDA product code for G7 ACETABULAR SYSTEM is PBI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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